Requests for authorised prescriber endorsement

Under certain circumstances, where patients may require access to medicines or medical devices that have not been approved for use in Australia by the Therapeutic Goods Administration (TGA), a medical practitioner may be granted authority (under section 19(5) of the Therapeutic Goods Act) to become an authorised prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients for a particular indication.

In order to grant authorised prescriber status, the TGA must be satisfied of the following:

  • the medical practitioner has the training and expertise appropriate for the condition being treated and the proposed use of the product;
  • the Authorised Prescriber must be able to best determine the needs of the patient; and
  • to monitor the outcome of therapy.

In order to apply to the TGA to become an authorised prescriber, practitioners must be endorsed by a Human Research Ethics Committee, or, where they do not have access to an appropriate HREC, a relevant specialist college. When a practitioner in engaged in clinical practice in a hospital, the HREC of that hospital should provide the endorsement.

To apply to the St Vincent’s Hospital (Sydney) HREC for endorsement to apply to the TGA as an Authorised Prescriber, clinicians are required to submit the following:

  • Completed application for HREC endorsement for the purpose of becoming an Authorised Prescriber which is available on the Standard Forms and Templates page. This is required for both new and renewal applications
  • Consumer medical information if the product is approved in another country
  • Relevant literature regarding product use
  • For devices, a copy of the manufacturer instructions for use
  • A copy of the completed TGA form; ‘Agreement to treatment directions authorisation of prescribers under section 19(5), 32CM or section 41HC of the Therapeutic Goods Act 1989’
  • For renewal applications, 6 monthly reports which have been submitted to the TGA
  • Any other documents relevant to submission

For more information regarding the Authorised Prescriber scheme, including the TGA application form for authorised prescribers, please refer to the TGA website - Access to Unapproved Products.